Trial Title:
Sustaining Physical Activity After Cancer Exercise Sessions
NCT ID:
NCT06359210
Condition:
Exercise Oncology
Physical Activity Behavior
Behavior Change Interventions
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
exercise oncology
physical activity
behavior change
adaptive intervention
cancer survivors
physical activity maintenance
community partnerships
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
An adaptive design results in a final total of 4 possible subgroups, depending upon
responder/non-responder status, and researchers plan to compare the proportion of
participants achieving the minimum exercise guidelines for cancer survivors within the
responders and incomplete responder subgroups. Admittedly however, it is not possible to
fully elucidate the analyses the researchers will conduct, as researchers cannot predict
the number of subgroups that participants will represent at the end of the trial (e.g.,
if there are no "incomplete responders" the design reduces to randomization to only two
groups), nor the number of participants who will be in those subgroups
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Responder Monthly Behavior Change Discussion Sessions
Description:
Monthly behavior change discussion sessions (3 total) for 12 weeks.
Arm group label:
Group B- Complete Responder
Intervention type:
Behavioral
Intervention name:
Incomplete Responder Monthly Behavior Change Discussion Sessions
Description:
Monthly behavior change discussion sessions (3 total) for 12 weeks.
Arm group label:
Group C- Incomplete Responder
Intervention type:
Behavioral
Intervention name:
Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions
Description:
Monthly behavior change discussion sessions (3 total) for 12 weeks and attend bi-weekly
(every other week) exercise classes that mirror the exercises completed in their
respective community-based exercise program.
Arm group label:
Group D- Incomplete Responder
Summary:
The goal of this clinical trial is to develop and test an adaptive physical activity (PA)
maintenance intervention for cancer survivors, after participating in a community-based
exercise oncology program. The main questions it aims to answer are:
- Aim 1: Examine the feasibility and acceptability of the intervention among cancer
survivors and community partners. The researchers will utilize quantitative surveys,
focus groups, and semi-structured interviews to collect information about
feasibility, implementation, adaptation, and sustainability.
- Aim 2: Examine the effects of the intervention among cancer survivors. The
researchers will compare the proportion of participants achieving the exercise
guidelines for cancer survivors six-months following completion of the initial
exercise program.
Participants will participate in a community-based exercise oncology program and then
return to three months of free living. Based on the PA measured at the three-month
follow-up, participants will be categorized as a "Responder" or "Incomplete Responder",
and then randomized to the PA maintenance intervention. Researchers will compare those
that are classified as Responders (meeting exercise guidelines for cancer survivors) and
Incomplete Responders (not meeting guidelines for cancer survivors) to see what level of
intervention is needed to influence sustainable behavior change in this population.
Detailed description:
Structured leisure-time physical activity (PA) (i.e., aerobic and resistance exercise) is
effective for improving multiple health outcomes related to a cancer diagnosis and cancer
treatment and may reduce cancer-specific mortality by as much as 40%. Thus, if cancer
survivors can achieve and maintain recommended exercise levels, the public health impact
would be substantial.
Supervised exercise interventions that include theory-based behavior change strategies
are effective for facilitating increases in moderate to vigorous, leisure-time PA among
cancer survivors. However, few studies have focused on maintaining exercise or PA levels
following completion of an intervention, and evidence regarding how exercise
interventions for cancer survivors can be expanded to clinic or community practice is
only now emerging. To achieve the physical, psychosocial, and survival benefits of
exercise, survivors must be able to maintain PA long-term, and to support PA maintenance,
a socio-ecological approach is necessary. Our approach is informed by theoretical
frameworks including social cognitive theory and group dynamics, which will guide
intrapersonal and interpersonal level intervention strategies. Integrated
research-practice partnership models will guide strategies to address organizational and
community-level influences.
The goal is to develop and test an adaptive randomized trial to enhance PA maintenance
among cancer survivors. Our central hypothesis is that participants who have difficulty
maintaining PA following a community-based exercise program will benefit from additional
support in the form of bi-weekly exercise sessions and/or PA behavior change discussion
sessions. Our long-term goal is to develop an evidence-based 'stepped' PA maintenance
intervention for cancer survivors that can be disseminated to existing community-based
cancer-exercise programs nationwide. In the proposed study, cancer survivors will
participate in an existing, cancer-specific exercise program at a community-based
facility.
All programs will consist of group-based, supervised, instructor-led aerobic and
resistance exercise sessions 2x per week, and three PA behavior change discussion
sessions. Upon completion of the program, participants will be encouraged to maintain PA
levels during a three-month free-living period, during which time there will be no active
intervention. After this follow-up period, PA will be measured, and based on PA response
(i.e., achieving exercise guidelines for cancer survivors), participants will be
randomized to a 3-month, stepped, PA maintenance intervention. The primary outcome of PA
maintenance will be assessed six-months after completion of the initial exercise program.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥18 years old,
- Able to speak/read English,
- Diagnosed with any type of cancer,
- Completed primary or adjuvant treatment (i.e., chemotherapy, radiation therapy,
surgery) within the previous five years, with no planned treatment within the next
nine months. This does not include long-term or chronic therapies such as
anti-hormone or targeted therapies (e.g., aromatase inhibitor, androgen deprivation
therapy),
- Participant is registered/enrolled to participate in one of three community-based
exercise programs.
Exclusion Criteria:
- Existing participation in ≥90 minutes per week of at least moderate intensity
aerobic exercise AND two or more days per week of resistance exercise or known
contraindications for exercise.
- Known contraindications for non-medically supervised moderate or greater intensity
exercise (e.g., uncontrolled hypertension, inability to walk without an assistive
device)
- Current or planned participation in another exercise oncology program (not one of
the three community partner exercise programs), or previous participation in another
or one of the three community partner exercise programs in the past 12-months.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anschutz Medical Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ryan Marker, PhD, PT
Phone:
720-848-0300
Email:
ryan.marker@cuanschutz.edu
Investigator:
Last name:
Ryan Marker, PhD, PT
Email:
Sub-Investigator
Facility:
Name:
Colorado State University
Address:
City:
Fort Collins
Zip:
80526
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather J Leach, PhD
Phone:
970-491-8951
Email:
heather.leach@colostate.edu
Investigator:
Last name:
Heather J Leach, PhD
Email:
Principal Investigator
Facility:
Name:
University of Wyoming
Address:
City:
Laramie
Zip:
82072
Country:
United States
Status:
Recruiting
Contact:
Last name:
Derek Smith, PhD
Phone:
307-766-5271
Email:
smithdt@uwyo.edu
Investigator:
Last name:
Derek Smith, PhD
Email:
Sub-Investigator
Start date:
March 4, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Colorado State University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Colorado State University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06359210
